MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS; REPLACEMENT HEART-VALVE

Model Number	2800TFX23MM
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient with a 23mm 2800tfx aortic valve implanted in pulmonary position for eight (8) years, underwent valve-in-valve procedure due to severe pulmonary stenosis and moderate regurgitation.It was reported patient had minimal symptoms due to digeorge developmental delay, moderate to severe rv dilation indication.Tpvr was successfully performed with a 23mm 9600tfx transcatheter valve.
Additional Manufacturer Narrative
The device was not returned to edwards for evaluation as it remains implanted.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all events.Trends are monitored on a the investigation is still in progress; therefore, a conclusion has yet to be established.
Additional Manufacturer Narrative
Added information to h6.Based on the information available, the device was intentionally used outside the way it was designed and intended.The performance, safety, efficacy, longevity, and durability of bioprosthetic valves have not been determined when the product is used outside the scope of its intended use and/or its studied population.Regurgitation is a common manifestation of bioprosthetic valve and valved conduit dysfunction.Common causes of regurgitation during device implantation include: device distortion occurring before or during implant; device interaction with patient anatomy or other devices; leaflet damage occurring before or during implant, and incorrectly sized valve seated.The above factors may occur during the procedure due to patient anatomical factors and/or other procedural difficulties even if the device is used within specification and within acceptable medical practice.Although it is uncommon, the procedural factors listed above may be the result of use of the device not in accordance with the ifu either inadvertently or intentionally.It is possible that distortion of the valve frame or damage to the leaflets incurred during the manufacturing process may result in regurgitation if undetected during device preparation.Visually apparent valve or leaflet anomalies are typically detected prior to implantation, resulting in device exchange.Complaints reported with regurgitation as the primary complaint code are not typically attributed to manufacturing-related nonconformances.A device history record (dhr) review [was performed, and no relevant non-conformances were identified.Or unable to be performed as no s/n was provided].There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.Based on the information available, the most likely root cause is patient, including patient age at time of implant, and digeorge syndrome.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 22983317
• Report Number: 2015691-2025-07317
• Device Sequence Number: 9549340
• Product Code: DYE
• UDI-Device Identifier: 00690103194098
• UDI-Public: (01)00690103194098(17)210601
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: 2800TFX23MM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 16 YR
• Patient Sex: Male